Such market exclusivity can produce hundreds of millions of dollars in revenue for the manufacturer.
"There is strong opposition amongst Australian health organisations to lengthening market exclusivity for biologics.
But under American pressure, Thailand had created a program that conferred the same market exclusivity.
In a separate order, the judge denied a motion filed by the company to preserve market exclusivity.
These barriers would suggest that biologic drugs should need fewer, not more, years of market exclusivity than conventional drugs have.
Orphan drug status entitles a company to tax credits and seven years of "market exclusivity," or freedom from generic competition.
During this period of market exclusivity, the patent owner can recover the costs of its original investment.
The patent covering Plavix gives market exclusivity to Bristol-Myers and Sanofi until the end of 2011.
To make this regulation palatable, the F.D.A. continues to offer a six-month extension of market exclusivity for drug companies that perform pediatric studies.
He strongly urged the government not to give Plan B One-Step's maker, Teva Pharmaceuticals, market exclusivity, which could affect the availability and cost of generic versions.
The ban was issued in July after Apotex challenged Alpharma's right to six months of market exclusivity for gabapentin, the crucial ingredient in the medicine.
